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Zacks News
Lisata's (LSTA) LSTA1 Gets FDA's RPDD Tag for Osteosarcoma
by Zacks Equity Research
Lisata's (LSTA) lead investigational product candidate, LSTA1, gets Rare Pediatric Disease Designation for treating osteosarcoma. Stock rises.
Novo Nordisk (NVO) Gets Positive CHMP Opinion for Insulin Icodec
by Zacks Equity Research
Novo Nordisk (NVO) receives a positive opinion from the CHMP for once-weekly basal insulin icodec for the treatment of diabetes in adults.
Merck's (MRK) Keytruda-Lynparza Combo Fails 2nd Lung Cancer Study
by Zacks Equity Research
Merck's attempt to use the Keytruda-Lynparza combination in certain non-small cell lung cancer patients has come up short with a second pivotal study failure.
ANI Pharmaceuticals (ANIP) Outpaces Stock Market Gains: What You Should Know
by Zacks Equity Research
ANI Pharmaceuticals (ANIP) closed at $69.32 in the latest trading session, marking a +1.7% move from the prior day.
Lifecore (LFCR) Down 30% on Ending Strategic Review With No Deal
by Zacks Equity Research
Lifecore (LFCR) ends a year-long strategic review and will continue its operations on a stand-alone basis. The company also names a new CEO effective from May 20.
ACELYRIN (SLRN) Up on Data From Thyroid Eye Disease Study
by Zacks Equity Research
ACELYRIN (SLRN) posts positive proof-of-concept data from a phase I/II study evaluating its pipeline candidate, lonigutamab, for treating thyroid eye disease. Stock gains.
Bristol Myers (BMY) Gets EC Nod for Abecma's Label Expansion
by Zacks Equity Research
Bristol Myers (BMY) wins European Commission's approval for the label expansion of its CAR T cell immunotherapy Abecma in earlier lines for triple-class exposed relapsed and refractory multiple myeloma.
PTC Therapeutics (PTCT) Up on Positive Regulatory Updates
by Zacks Equity Research
PTC Therapeutics (PTCT) submits BLA for gene therapy Upstaza to the FDA and announces plans to resubmit its application for Translarna to the regulatory body. Its shares rise on these updates.
Bayer's (BAYRY) Elinzanetant Meets Goals in Third Phase III Study
by Zacks Equity Research
Bayer's (BAYRY) pipeline candidate, elinzanetant, achieves primary and secondary goals in late-stage OASIS 3 study supporting submissions for marketing authorization.
Axsome (AXSM) Begins Dosing in Depression Study on Sunosi
by Zacks Equity Research
Axsome (AXSM) doses the first patient in the phase III PARADIGM study evaluating Sunosi (solriamfetol) for treating major depressive disorder. The stock rises 6%.
ANI (ANIP) Is Considered a Good Investment by Brokers: Is That True?
by Zacks Equity Research
According to the average brokerage recommendation (ABR), one should invest in ANI (ANIP). It is debatable whether this highly sought-after metric is effective because Wall Street analysts' recommendations tend to be overly optimistic. Would it be worth investing in the stock?
ANI Pharmaceuticals (ANIP) Gains But Lags Market: What You Should Know
by Zacks Equity Research
ANI Pharmaceuticals (ANIP) reachead $67.87 at the closing of the latest trading day, reflecting a +0.37% change compared to its last close.
Intellia (NTLA) Begins Dosing in Phase III ATTR Amyloidosis Study
by Zacks Equity Research
Intellia (NTLA) doses the first patient in the phase III MAGNITUDE study on NTLA-2001 for treating transthyretin amyloidosis with cardiomyopathy.
Cybin (CYBN) Begins Phase II Study on Anxiety Drug, Stock Up
by Kanishka Das
Cybin (CYBN) initiates a phase II proof-of-concept study evaluating CYB004 for the treatment of generalized anxiety disorder. The stock rises 7.2%.
Immuneering (IMRX) Plummets 71% in One Week: Here's Why
by Zacks Equity Research
Immuneering (IMRX) plunges after multiple Wall Street analysts downgraded the stock on lackluster results from an early-stage study evaluating its lead drug across advanced RAS-mutant solid tumors.
Allogene's (ALLO) Q4 Loss Narrower Than Expected, Sales Miss
by Zacks Equity Research
Allogene's (ALLO) fourth-quarter earnings beat estimates, but sales miss the mark. Management expects operating expenses for 2024 to be around $280 million.
Is ANI Pharmaceuticals (ANIP) Stock Outpacing Its Medical Peers This Year?
by Zacks Equity Research
Here is how ANI Pharmaceuticals (ANIP) and AnaptysBio, Inc. (ANAB) have performed compared to their sector so far this year.
Lexicon (LXRX) Dips on Post Hoc Analysis Data on Sotagliflozin
by Zacks Equity Research
New post hoc analysis of data from Lexicon's (LXRX) phase III study shows improvements in glycemic control when treated with sotagliflozin for type 1 diabetes and chronic kidney disease.
Allogene (ALLO) Inks Deal With Arbor Bio for CRISPR Technology
by Zacks Equity Research
Allogene (ALLO) intends to combine its next generation AlloCAR T platform with Arbor Biotechnologies' proprietary CRISPR gene therapy technology to develop therapies for autoimmune diseases.
Regulus (RGLS) Up 71% on Topline Data from Kidney Disease Study
by Zacks Equity Research
Data from an early-stage study shows that treatment with Regulus' (RGLS) lead drug shows increased biological activity at a higher dose in patients with autosomal dominant polycystic kidney disease.
Why Moderna (MRNA) Stock Price Was Up 9% on Monday
by Zacks Equity Research
Moderna (MRNA) surges amid initiation reports of a phase II/III study on Merck-partnered experimental cancer therapy to treat patients with cutaneous squamous cell carcinoma, a form of skin cancer.
Amylyx's (AMLX) ALS Drug Fails Pivotal Study, Stock Down 82%
by Zacks Equity Research
Following the study's failure, Amylyx (AMLX) is now uncertain whether to pull its orally administered ALS drug from the market. Management has voluntarily decided to pause all promotions of the drug.
MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a breakthrough therapy designation to MindMed's (MNMD) MM120 for treating generalized anxiety disorder. Shares rise more than 50% on the news.
Emergent (EBS) Down 16% on Q4 Earnings Miss, Tops on Sales
by Zacks Equity Research
Emergent (EBS) reports mixed earnings for fourth-quarter 2023. The company signs a forbearance agreement with its lenders, effective till April 2023-end.
Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
by Zacks Equity Research
Creative Medical's (CELZ) CELZ-101 gets FDA's Orphan Drug designation for preventing allograft rejection in type-I diabetes patients undergoing pancreatic islet cell transplantation. Stock rises.